Product Code
2010700

The INDICAID® COVID-19 IgM/IgG Rapid Test(CE-IVD, FDA EUA) detects anti-SARS-CoV-2 IgM/IgG antibodies in human whole blood (venous or fingerstick), serum or plasma.

Product Advantage

Fast: Intuitive visual results in 10 minutes
Accurate: Overall specificity and sensitivity at 99.9% and 97% respectively
Easy-to-Use: No special equipment or facilities needed

Principle

Antibodies can be detected as early as one week after infection.

Antibodies produced by the human body to fight viral infections can be used as markers for disease exposure.

Immunoglobulin M (IgM) is the first class of antibody to be produced and may indicate active or recent infection. Immunoglobulin G (IgG) antibodies are produced at a later stage and remain even after disease resolution, which may indicate recent or prior infection.

Instruction For Use

1

Open the package and
take out the test device

2

Wipe the fingertip with an alcohol pad.

3

Prick the cleaned fingertip with the lancet.

4

Collect blood from the fingertip using the dropper.

5

Apply all of the blood into the sample well of the test device.

6

Apply 2 drops of the buffer solution onto the sample well of the device.

7

Leave for 10 minutes and read the results. Do not read after 15 minutes.

Interpretation of Result

INDICATOR RESULT INTERPRETATION
A line appears in regions (C), (IgG) and (IgM) Positive The presence of the control line (C) and both the IgM line (IgM) and IgG line (IgG) indicates the presence of both SARS-CoV-2 IgM and IgG antibodies. The result suggests current or recent COVID-19 infection.
A line appears in regions (C) and (IgM) Positive The presence of the control line (C) and only the IgM line (IgM) indicates the presence of SARS-CoV-2 IgM antibodies. The result suggests an active or recent COVID-19 infection.
A line appears in regions (C) and (IgG) Positive The presence of the control line (C) and only the IgG line (IgG) indicates the presence of SARS-CoV-2 IgG antibodies. The result suggests a recent or previous COVID-19 infection.
A line appears in the region (C) Negative The presence of only the control line (C) and neither the IgM line (IgM) or the IgG line (IgG), indicates no detection of SARS-CoV-2 IgM or IgG antibodies.
No line appears in the region (C) Invalid If the control line (C) does not appear, the result is invalid, regardless whether the IgM line (IgM) or the IgG line (IgG) is present. Repeat the test with a new test kit.

Limitations

  • The test result cannot be used for diagnosis of COVID-19. If the result does not match the clinical evaluation, a confirmatory test may be required. Do not use highly hemolytic samples. Do not reuse the test device.

  • The test kit can only be used with whole blood (from venous or fingerstick), serum or plasma. Using other samples may produce inaccurate results.

  • Read the result at 10 minutes. Do not interpret the result after 15 minutes.

  • Please follow the product insert when testing.

Data / Performance

The performance of INDICAID® COVID-19 IgM/IgG Rapid Test Kit has been validated clinically. Below are the results of in-house and independent clinical validation.

In-house Clinical Validation

The INDICAID® COVID-19 IgM/IgG Rapid Test Device was tested on clinical specimens from 60 healthy persons and 70 identified COVID-19 patients, using PCR as the reference method. The results are summarized as below.

Clinical Performance of Negative Sample
Negative cases (By PCR) 60
Negative coincidence rate (COVID-19 IgM) 60 (100%)
Negative coincidence rate (COVID-19 IgG) 60 (100%)
Negative coincidence rate (Total) 60 (100%)
Clinical Performance of Positive Sample
Positive cases (By PCR) 70
Positive coincidence rate (COVID-19 IgM) 68 (97.1%)
Positive coincidence rate (COVID-19 IgG) 67 (95.7%)
Positive coincidence rate (Total) 68 (97.1%)

Figure 1 - The results show that the relative specificity is 100%, the relative sensitivity is 97.1%, and the overall accuracy is 98.5%

Independent Clinical Validation

50 positive and 50 negative patient samples (confirmed with RT-PCR) were independently tested with INDICAID® IgM/IgG Rapid Test Kit at a top Hong Kong university. In the study, the overall sensitivity and specificity were determined to be 96% (48/50) and 96% (48/50), respectively.

I. Result of Negative Samples

Figure 2 – Plasma was extracted from 50 RT-PCR tested negative COVID-19 patient blood samples. 10 µL plasma sample was then tested using the INDICAID® COVID-19 IgM/IgG Rapid Test Kit, followed by 2 drops of running buffer. The result was interpreted after 10 minutes, and the respective test line intensities were measured. The rapid test results of 48 out of 50 samples were shown to be in line with the RT-PCR results, showing an overall specificity of 96%.

II. Result of Positive Samples

Figure 3 – 10 µL of plasma extracted from 50 RT-PCR tested positive COVID-19 patient blood samples were tested using the INDICAID® COVID-19 IgM/IgG Rapid Test Kit, followed by 2 drops of running buffer. The results was interpreted after 10 minutes, and the respective test line intensities were measured. The rapid test results of 48 out of 50 samples were shown to be in line with the RT-PCR results, showing an overall sensitivity of 96%.

Frequently Asked Questions (FAQs)

a. I ACCIDENTALLY SPILLED THE TEST SOLUTION. IS IT HARMFUL?

The test solution is not harmful. Flush abundantly with water upon disposal.Avoid having the test solution come into contact with your eyes, skin and mouth. If contact occurs with the eyes, flush with water immediately and seek medical help. If contact occurs with your skin or mouth, wash the area with soap and rinse with water.

b. WHAT DO I DO WITH THE TEST UNIT AFTER READING THE RESULTS?

After recording your results, carefully wrap and seal all product components and dispose by throwing it into the garbage just like any household trash. Use a sharps box if one is available.

c. HOW DOES THE TEST WORK?

This test is designed to detect the presence of SARS-CoV-2 virus fighting antibodies in human whole blood. Antibodies produced by the human body to fight viral infections can be used as markers for disease exposure.

d. WHAT ARE IgM and IgG ANTIBODIES?

As your body starts to fight off infection, your immune system produces immunoglobulin M (IgM) antibodies. IgM is the first class of antibody to be produced by the human body, and may indicate active or recent infection. IgM antibodies generally appear several days after symptoms begin and can last 1-8 weeks.As your body continues to fight off infection, it produces fewer IgM antibodies and more long lasting immunoglobulin G (IgG) antibodies. IgG antibodies are produced at a later stage and remain even after disease resolution, which may indicate recent or prior infection.

e. WHAT IF I TESTED NEGATIVE?

Rapid antibody tests can only detect the presence of antibodies at the time of the test, and do not rule out COVID-19 infection. If you had contact with a known or suspected COVID-19 cases, as a best practice, performing the test once every week is recommended.

f. WHAT IF I TESTED POSITIVE?

If you tested positive for COVID-19 antibodies, we recommend contacting your local health authorities to organize a follow-up molecular diagnostics test for diagnosis.

g. HOW ACCURATE IS THE TEST?

The INDICAID® COVID-19 IgM/IgG Rapid Test has been clinically validated reach a high detection accuracy, reaching a relative detection specificity of 99% and a relative detection sensitivity of 97.1%.In our clinical study, the INDICAID® COVID-19 IgM/IgG Rapid Test device was tested on clinical specimens from 60 healthy persons and 70 identified C OVID-19 patients, using PCR as the reference method. The results are summarized as below.

Product Resources

User Manual
Quick Start Guide
Product Catalogue
Safety Data Sheets (SDS)

Product Sales and Customer Services

Email : phasify@phasesci.com | Customer Service : Hong Kong +852 3892-7200 (9am - 6pm UTC+8)
US +1 (657) 233-5880 (9am - 6pm Pacific)
Technical Support : Hong Kong +852 9135-2170 (9am - 6pm UTC+8)
US +1 (657) 296-6106 (9am - 6pm Pacific)
Email : phasify@phasesci.com
Customer Service :
Hong Kong +852 3892-7200
(9am - 6pm UTC+8)
US +1 (657) 233-5880
(9am - 6pm Pacific)
Technical Support :
Hong Kong +852 9135-2170
(9am - 6pm UTC+8)
US +1 (657) 296-6106
(9am - 6pm Pacific)